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A Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Participants With Crohn's Disease

Primary Purpose

Crohn's Disease (CD)

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ABT-494
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease (CD) focused on measuring Crohn's Disease, Efficacy, Safety, Tolerability, ABT-494

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participant must have completed Study M13-740 through Week 52.
  • If female, participant must be postmenopausal, surgically sterile or on using a birth control method.

Exclusion Criteria:

  • For any reason participant is considered by the investigator to be an unsuitable candidate
  • Female participant with a positive pregnancy test at Baseline or who is considering becoming pregnant during the study.
  • Participant is not in compliance with prior and concomitant medication requirements and procedures throughout Study M13-740.

Sites / Locations

  • UC San Diego Health System /ID# 150041
  • Univ California, San Francisco /ID# 149987
  • University of Florida - Archer /ID# 150033
  • The Ctr for Gastro Disorders /ID# 150012
  • Nature Coast Clinical Research - Inverness /ID# 149975
  • Gastroenterology Associates of Central Georgia, LLC /ID# 149870
  • GI Specialists of GA, PC /ID# 150015
  • Cotton-O'Neil Clinical Res Ctr /ID# 149900
  • University of Louisville /ID# 149884
  • Investigative Clinical Research /ID# 149886
  • Charm City Research Group /ID# 150040
  • Clin Res Inst of Michigan, LLC /ID# 150008
  • Mayo Clinic - Rochester /ID# 149894
  • Kansas City Research Institute /ID# 149888
  • Washington University-School of Medicine /ID# 149899
  • NYU Langone Long Island Clinical Research Associates /ID# 149976
  • Weill Cornell Medicine/NYP /ID# 149895
  • Univ NC Chapel Hill /ID# 149982
  • University of Cincinnati /ID# 149977
  • Options Health Research, LLC /ID# 150010
  • Texas Digestive Disease Consultants - Southlake /ID# 149869
  • Texas Digestive Disease Consultants - Southlake /ID# 149989
  • Aspen Clinical Research /ID# 150020
  • University of Virginia /ID# 149881
  • Virginia Mason Medical Center /ID# 150042
  • University of Washington /ID# 149988
  • Wisconsin Center for Advanced Research, a division of GI Associates, LLC /ID# 149863
  • CHU de Liege /ID# 149912
  • University of Alberta - Zeidler Ledcor Centre /ID# 149873
  • University of British Columbia (UBC) - Gordon and Leslie Diamond Health Care Ce /ID# 149876
  • GIRI Gastrointestinal Research Institute /ID# 149878
  • Toronto Digestive Disease Asso /ID# 149877
  • Royal Victoria Hospital / McGill University Health Centre /ID# 149871
  • Hepato-Gastroenterologie HK, s.r.o. /ID# 149882
  • Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 149890
  • Aarhus University Hospital /ID# 149919
  • CHRU Lille - Hopital Claude Huriez /ID# 149897
  • CHRU Nancy - Hopitaux de Brabois /ID# 149896
  • CHU Amiens-Picardie Site Sud /ID# 149921
  • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 149936
  • DRK Kliniken Berlin Westend /ID# 149905
  • Medizinisches Versorgungszentrum Portal 10 /ID# 149930
  • Magyar Elhizastudomanyi Kozpont Kft. /ID# 149907
  • The Chaim Sheba Medical Center /ID# 149945
  • Assaf Harofeh Medical Center /ID# 149943
  • Rabin Medical Center /ID# 149942
  • University of Catanzaro /ID# 149927
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 149958
  • Academisch Medisch Centrum /ID# 149932
  • Universitair Medisch Centrum Utrecht /ID# 149933
  • Dunedin Hospital /ID# 149964
  • Lovisenberg Diakonale Sykehus /ID# 149967
  • Centrum Medyczne Szpital Swietej Rodziny /ID# 149979
  • Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 149978
  • Cabinet Particular Policlinic Algomed /ID# 149993
  • KM Management, spol. s.r.o. /ID# 149949
  • GASTRO I., s.r.o. /ID# 149948
  • Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 149996
  • Hospital Universitario La Paz /ID# 149997
  • Oxford University Hospitals NHS Foundation Trust /ID# 149963
  • Manchester University NHS Foundation Trust /ID# 150006

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Upadacitinib (ABT-494) Dose A

Upadacitinib (ABT-494) Dose B

Arm Description

Open label dose A once daily (QD)

Open label dose B QD

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving Remission
It is defined as the percentage of participants achieving clinical remission and endoscopic remission.
Percentage of Participants in Remission at Week 0 Who Maintain Remission
Remission is defined as participants achieving clinical remission and endoscopic remission.
Percentage of Participants Achieving Response
It is defined as the percentage of participants achieving clinical response and endoscopic response.
Percentage of Participants Achieving Clinical Remission
Clinical remission is defined based on the patient reported outcomes: average daily stool frequency and average daily abdominal pain.
Percentage of Participants Achieving Modified Clinical Remission
Clinical remission is defined as change from baseline in the patient reported outcomes: average daily stool frequency and average daily abdominal pain.
Percentage of Participants Achieving Enhanced Clinical Response
Enhanced clinical response is defined as change from baseline in the patient reported outcomes: average daily stool frequency and average daily abdominal pain.
Percentage of Participants Achieving Clinical Response
Clinical response is defined as change from baseline in the patient reported outcomes: average daily stool frequency and average daily abdominal pain.
Percentage of Participants Achieving Endoscopic Remission
Endoscopic remission is based on Simplified Endoscopic Score for Crohn's disease.
Percentage of Participants in Endoscopic Remission at Week 0 Who Maintain Endoscopic Remission
Endoscopic remission is based on Simplified Endoscopic Score for Crohn's disease.
Percentage of Participants Achieving Endoscopic Improvement
Endoscopic improvement is based on changes from baseline on the Simplified Endoscopic Score for Crohn's disease or endoscopic remission.
Percentage of Participants Achieving Endoscopic Response
Endoscopic response is based on changes from baseline on the Simplified Endoscopic Score for Crohn's disease.
Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Remission
It is defined as CDAI less than 150.
Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Response
CDAI response is defined as a reduction in CDAI by >= 70 from baseline of Study M13-740.
Percentage of Participants Achieving Enhanced CDAI Response
Enhanced CDAI response is defined as reduction in CDAI by >= 100 from baseline of Study M13-740.
Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission
IBDQ remission is defined as IBDQ >= 170.
Percentage of Participants Achieving IBDQ Response
IBDQ response is defined as an increase in IBDQ score >= 16 point from Baseline of Study M13-740.
Percentage of Participants Taking Steroids at Baseline (of Study M13-740) Who Are Steroid-Free
Percentage of participants taking steroids at Baseline (of Study M13-740) who are steroid-free
Percentage of Participants Taking Steroids at Baseline (of Study M13-740) Who Are Steroid-Free for At Least 90 Days and Achieve Remission
Percentage of participants taking steroids at Baseline (of Study M13-740) who are steroid-free for at least 90 days over time and achieve Remission
Percentage of Participants Achieving Remission and Normal C-Reactive Protein
Percentage of participants achieving Remission and normal C-reactive protein. Remission is defined as Clinical Remission AND Endoscopic Remission.

Secondary Outcome Measures

Full Information

First Posted
May 23, 2016
Last Updated
May 2, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT02782663
Brief Title
A Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Participants With Crohn's Disease
Official Title
A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects With Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 18, 2016 (Actual)
Primary Completion Date
September 17, 2025 (Anticipated)
Study Completion Date
September 17, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a open-label extension (OLE) study designed to evaluate the long-term efficacy, safety, and tolerability of Upadacitinib (ABT-494).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease (CD)
Keywords
Crohn's Disease, Efficacy, Safety, Tolerability, ABT-494

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Upadacitinib (ABT-494) Dose A
Arm Type
Experimental
Arm Description
Open label dose A once daily (QD)
Arm Title
Upadacitinib (ABT-494) Dose B
Arm Type
Experimental
Arm Description
Open label dose B QD
Intervention Type
Drug
Intervention Name(s)
ABT-494
Other Intervention Name(s)
Upadacitinib, RINVOQ
Intervention Description
Tablet: Oral
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Remission
Description
It is defined as the percentage of participants achieving clinical remission and endoscopic remission.
Time Frame
Up to Month 96
Title
Percentage of Participants in Remission at Week 0 Who Maintain Remission
Description
Remission is defined as participants achieving clinical remission and endoscopic remission.
Time Frame
Up to Month 96
Title
Percentage of Participants Achieving Response
Description
It is defined as the percentage of participants achieving clinical response and endoscopic response.
Time Frame
Up to Month 96
Title
Percentage of Participants Achieving Clinical Remission
Description
Clinical remission is defined based on the patient reported outcomes: average daily stool frequency and average daily abdominal pain.
Time Frame
Up to Month 96
Title
Percentage of Participants Achieving Modified Clinical Remission
Description
Clinical remission is defined as change from baseline in the patient reported outcomes: average daily stool frequency and average daily abdominal pain.
Time Frame
Up to Month 96
Title
Percentage of Participants Achieving Enhanced Clinical Response
Description
Enhanced clinical response is defined as change from baseline in the patient reported outcomes: average daily stool frequency and average daily abdominal pain.
Time Frame
Up to Month 96
Title
Percentage of Participants Achieving Clinical Response
Description
Clinical response is defined as change from baseline in the patient reported outcomes: average daily stool frequency and average daily abdominal pain.
Time Frame
Up to Month 96
Title
Percentage of Participants Achieving Endoscopic Remission
Description
Endoscopic remission is based on Simplified Endoscopic Score for Crohn's disease.
Time Frame
Up to Month 96
Title
Percentage of Participants in Endoscopic Remission at Week 0 Who Maintain Endoscopic Remission
Description
Endoscopic remission is based on Simplified Endoscopic Score for Crohn's disease.
Time Frame
Up to Month 96
Title
Percentage of Participants Achieving Endoscopic Improvement
Description
Endoscopic improvement is based on changes from baseline on the Simplified Endoscopic Score for Crohn's disease or endoscopic remission.
Time Frame
Up to Month 96
Title
Percentage of Participants Achieving Endoscopic Response
Description
Endoscopic response is based on changes from baseline on the Simplified Endoscopic Score for Crohn's disease.
Time Frame
Up to Month 96
Title
Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Remission
Description
It is defined as CDAI less than 150.
Time Frame
Up to Month 96
Title
Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Response
Description
CDAI response is defined as a reduction in CDAI by >= 70 from baseline of Study M13-740.
Time Frame
Up to Month 96
Title
Percentage of Participants Achieving Enhanced CDAI Response
Description
Enhanced CDAI response is defined as reduction in CDAI by >= 100 from baseline of Study M13-740.
Time Frame
Up to Month 96
Title
Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission
Description
IBDQ remission is defined as IBDQ >= 170.
Time Frame
Up to Month 96
Title
Percentage of Participants Achieving IBDQ Response
Description
IBDQ response is defined as an increase in IBDQ score >= 16 point from Baseline of Study M13-740.
Time Frame
Up to Month 96
Title
Percentage of Participants Taking Steroids at Baseline (of Study M13-740) Who Are Steroid-Free
Description
Percentage of participants taking steroids at Baseline (of Study M13-740) who are steroid-free
Time Frame
Up to Month 96
Title
Percentage of Participants Taking Steroids at Baseline (of Study M13-740) Who Are Steroid-Free for At Least 90 Days and Achieve Remission
Description
Percentage of participants taking steroids at Baseline (of Study M13-740) who are steroid-free for at least 90 days over time and achieve Remission
Time Frame
Up to Month 96
Title
Percentage of Participants Achieving Remission and Normal C-Reactive Protein
Description
Percentage of participants achieving Remission and normal C-reactive protein. Remission is defined as Clinical Remission AND Endoscopic Remission.
Time Frame
Up to Month 96

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant must have completed Study M13-740 through Week 52. If female, participant must be postmenopausal, surgically sterile or on using a birth control method. Exclusion Criteria: For any reason participant is considered by the investigator to be an unsuitable candidate Female participant with a positive pregnancy test at Baseline or who is considering becoming pregnant during the study. Participant is not in compliance with prior and concomitant medication requirements and procedures throughout Study M13-740.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
UC San Diego Health System /ID# 150041
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Univ California, San Francisco /ID# 149987
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-2204
Country
United States
Facility Name
University of Florida - Archer /ID# 150033
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
The Ctr for Gastro Disorders /ID# 150012
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Nature Coast Clinical Research - Inverness /ID# 149975
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452-4717
Country
United States
Facility Name
Gastroenterology Associates of Central Georgia, LLC /ID# 149870
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
GI Specialists of GA, PC /ID# 150015
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Cotton-O'Neil Clinical Res Ctr /ID# 149900
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
University of Louisville /ID# 149884
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Investigative Clinical Research /ID# 149886
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Charm City Research Group /ID# 150040
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Clin Res Inst of Michigan, LLC /ID# 150008
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Mayo Clinic - Rochester /ID# 149894
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905-0001
Country
United States
Facility Name
Kansas City Research Institute /ID# 149888
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Washington University-School of Medicine /ID# 149899
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
NYU Langone Long Island Clinical Research Associates /ID# 149976
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Weill Cornell Medicine/NYP /ID# 149895
City
New York
State/Province
New York
ZIP/Postal Code
10021-4872
Country
United States
Facility Name
Univ NC Chapel Hill /ID# 149982
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514-4220
Country
United States
Facility Name
University of Cincinnati /ID# 149977
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0585
Country
United States
Facility Name
Options Health Research, LLC /ID# 150010
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Texas Digestive Disease Consultants - Southlake /ID# 149869
City
Southlake
State/Province
Texas
ZIP/Postal Code
76092
Country
United States
Facility Name
Texas Digestive Disease Consultants - Southlake /ID# 149989
City
Southlake
State/Province
Texas
ZIP/Postal Code
76092
Country
United States
Facility Name
Aspen Clinical Research /ID# 150020
City
Orem
State/Province
Utah
ZIP/Postal Code
84058
Country
United States
Facility Name
University of Virginia /ID# 149881
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Virginia Mason Medical Center /ID# 150042
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
University of Washington /ID# 149988
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Wisconsin Center for Advanced Research, a division of GI Associates, LLC /ID# 149863
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
CHU de Liege /ID# 149912
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
University of Alberta - Zeidler Ledcor Centre /ID# 149873
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2X8
Country
Canada
Facility Name
University of British Columbia (UBC) - Gordon and Leslie Diamond Health Care Ce /ID# 149876
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
GIRI Gastrointestinal Research Institute /ID# 149878
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2K5
Country
Canada
Facility Name
Toronto Digestive Disease Asso /ID# 149877
City
Vaughan
State/Province
Ontario
ZIP/Postal Code
L4L 4Y7
Country
Canada
Facility Name
Royal Victoria Hospital / McGill University Health Centre /ID# 149871
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Hepato-Gastroenterologie HK, s.r.o. /ID# 149882
City
Hradec Kralove
ZIP/Postal Code
500 12
Country
Czechia
Facility Name
Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 149890
City
Hvidovre
State/Province
Hovedstaden
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Aarhus University Hospital /ID# 149919
City
Aarhus N
State/Province
Midtjylland
ZIP/Postal Code
8200
Country
Denmark
Facility Name
CHRU Lille - Hopital Claude Huriez /ID# 149897
City
Lille
State/Province
Hauts-de-France
ZIP/Postal Code
59037
Country
France
Facility Name
CHRU Nancy - Hopitaux de Brabois /ID# 149896
City
Vandoeuvre-les-Nancy
State/Province
Meurthe-et-Moselle
ZIP/Postal Code
54500
Country
France
Facility Name
CHU Amiens-Picardie Site Sud /ID# 149921
City
Amiens CEDEX 1
State/Province
Somme
ZIP/Postal Code
80054
Country
France
Facility Name
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 149936
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
DRK Kliniken Berlin Westend /ID# 149905
City
Berlin
ZIP/Postal Code
14050
Country
Germany
Facility Name
Medizinisches Versorgungszentrum Portal 10 /ID# 149930
City
Muenster
ZIP/Postal Code
48155
Country
Germany
Facility Name
Magyar Elhizastudomanyi Kozpont Kft. /ID# 149907
City
Budapest
ZIP/Postal Code
1124
Country
Hungary
Facility Name
The Chaim Sheba Medical Center /ID# 149945
City
Ramat Gan
State/Province
Tel-Aviv
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Assaf Harofeh Medical Center /ID# 149943
City
Be'Er Ya'Akov
ZIP/Postal Code
70300
Country
Israel
Facility Name
Rabin Medical Center /ID# 149942
City
Petakh Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
University of Catanzaro /ID# 149927
City
Catanzaro
State/Province
Calabria
ZIP/Postal Code
88100
Country
Italy
Facility Name
IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 149958
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Academisch Medisch Centrum /ID# 149932
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Universitair Medisch Centrum Utrecht /ID# 149933
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Dunedin Hospital /ID# 149964
City
Otago
ZIP/Postal Code
9016
Country
New Zealand
Facility Name
Lovisenberg Diakonale Sykehus /ID# 149967
City
Oslo
ZIP/Postal Code
0440
Country
Norway
Facility Name
Centrum Medyczne Szpital Swietej Rodziny /ID# 149979
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
90-302
Country
Poland
Facility Name
Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 149978
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Cabinet Particular Policlinic Algomed /ID# 149993
City
Timișoara
ZIP/Postal Code
300002
Country
Romania
Facility Name
KM Management, spol. s.r.o. /ID# 149949
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
GASTRO I., s.r.o. /ID# 149948
City
Presov
ZIP/Postal Code
080 01
Country
Slovakia
Facility Name
Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 149996
City
Ferrol
State/Province
A Coruna
ZIP/Postal Code
15405
Country
Spain
Facility Name
Hospital Universitario La Paz /ID# 149997
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Oxford University Hospitals NHS Foundation Trust /ID# 149963
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
Manchester University NHS Foundation Trust /ID# 150006
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Citations:
PubMed Identifier
34968730
Citation
D'Haens G, Panes J, Louis E, Lacerda A, Zhou Q, Liu J, Loftus EV Jr. Upadacitinib Was Efficacious and Well-tolerated Over 30 Months in Patients With Crohn's Disease in the CELEST Extension Study. Clin Gastroenterol Hepatol. 2022 Oct;20(10):2337-2346.e3. doi: 10.1016/j.cgh.2021.12.030. Epub 2021 Dec 27.
Results Reference
derived
Links:
URL
https://www.rxabbvie.com/
Description
This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.

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A Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Participants With Crohn's Disease

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